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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K230965
Device Name Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens
Applicant
Acuity Polymers, Inc.
1667 Lake Ave.
Bldg. 59, Suite 303
Rochester,  NY  14615
Applicant Contact Chavez Jose
Correspondent
Acuity Polymers, Inc.
1667 Lake Ave.
Bldg. 59, Suite 303
Rochester,  NY  14615
Correspondent Contact Chavez Jose
Regulation Number886.5916
Classification Product Code
HQD  
Date Received04/05/2023
Decision Date 06/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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